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Monoclonal Antibodies

Itacitinib + Alemtuzumab for T-Cell Leukemia

Phase 1
Waitlist Available
Led By Tapan M Kadia
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is testing the effects of combining itacitinib with alemtuzumab to treat patients with T-cell prolymphocytic leukemia.

Who is the study for?
Adults with T-cell prolymphocytic leukemia (T-PLL), whether they're facing it for the first time or have relapsed, can join this trial. They should be in decent physical shape (ECOG <=2) and not have had certain treatments a week before starting the study drugs. Women who can get pregnant must test negative for pregnancy.Check my eligibility
What is being tested?
The trial is testing Itacitinib and Alemtuzumab together to see if they're better than current treatments for T-PLL. Itacitinib blocks enzymes that cancer cells need, while Alemtuzumab may help the immune system fight cancer.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system's response, potential impact on liver and kidney function, blood cell counts changes, fatigue, and increased risk of infections.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events (AEs)
Secondary outcome measures
Duration of response (DOR)
Event-free survival
Overall survival
+2 more

Side effects data

From 2020 Phase 3 trial • 439 Patients • NCT03139604
34%
Thrombocytopenia
29%
Anaemia
25%
Oedema peripheral
22%
Hyperglycaemia
21%
Hypertension
20%
Diarrhoea
19%
Hypokalaemia
18%
Platelet count decreased
18%
Nausea
17%
Neutropenia
16%
Cytomegalovirus viraemia
16%
Pyrexia
15%
Cough
14%
Alanine aminotransferase increased
14%
Hypertriglyceridaemia
13%
Dyspnoea
13%
Fatigue
13%
Hypomagnesaemia
13%
Tremor
12%
Cytomegalovirus infection reactivation
12%
Abdominal pain
12%
Blood creatinine increased
12%
Constipation
11%
Decreased appetite
11%
Arthralgia
11%
Aspartate aminotransferase increased
11%
Dizziness
11%
Muscular weakness
11%
Vomiting
10%
Insomnia
9%
Fall
9%
Headache
8%
Upper respiratory tract infection
8%
Dry eye
8%
Dysuria
8%
Anxiety
8%
Back pain
7%
Blood cholesterol increased
7%
Hypotension
7%
Hyponatraemia
7%
Hypophosphataemia
7%
Pain in extremity
7%
Urinary tract infection
7%
Hypocalcaemia
7%
Neutrophil count decreased
7%
Dry mouth
7%
Cytomegalovirus infection
6%
Hypoalbuminaemia
6%
Pruritus
6%
White blood cell count decreased
6%
Asthenia
6%
Blood alkaline phosphatase increased
5%
Acute kidney injury
5%
Pneumonia
5%
Gamma-glutamyltransferase increased
5%
Oral candidiasis
5%
Rash
5%
Weight decreased
5%
Pancytopenia
5%
Dysgeusia
5%
Dyspepsia
5%
Epstein-Barr virus infection reactivation
4%
Hyperkalaemia
4%
Epistaxis
3%
Febrile neutropenia
3%
Oedema
3%
Rhinorrhoea
3%
Dry skin
3%
Leukopenia
3%
Nasopharyngitis
3%
Neuropathy peripheral
3%
Vision blurred
2%
Cystitis haemorrhagic
2%
Syncope
2%
Sepsis
1%
Thrombotic microangiopathy
1%
Graft versus host disease in gastrointestinal tract
1%
Viral haemorrhagic cystitis
1%
Bronchopulmonary aspergillosis
1%
Adenovirus infection
1%
Escherichia sepsis
1%
Failure to thrive
1%
Malignant neoplasm progression
1%
Ophthalmic herpes zoster
1%
Oral herpes
1%
Pulmonary embolism
1%
Septic shock
1%
Pneumonia influenzal
1%
Myopathy
1%
Steroid diabetes
1%
Pseudomonal sepsis
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Plus Corticosteroids
Itacitinib Plus Corticosteroids
Total

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (itacitinib, alemtuzumab)Experimental Treatment2 Interventions
CYCLE 1: Patients receive itacitinib PO QD on days 1-28 and alemtuzumab IV over 2 hours on days 15, 17, 19, 21, 23, 25, and 27 in the absence of disease progression of unacceptable toxicity. CYCLE 2 AND BEYOND: Patients receive itacitinib PO QD on day 1-28 and alemtuzumab IV over 2 hours on days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, and 27. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients who achieve a response (CR/CRi or PR) may receive itacitinib for up to 8 additional cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Itacitinib
2020
Completed Phase 3
~910
Alemtuzumab
2004
Completed Phase 4
~1890

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,766 Total Patients Enrolled
Tapan M KadiaPrincipal InvestigatorM.D. Anderson Cancer Center
13 Previous Clinical Trials
1,158 Total Patients Enrolled

Media Library

Alemtuzumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03989466 — Phase 1
Prolymphocytic Leukemia Research Study Groups: Treatment (itacitinib, alemtuzumab)
Prolymphocytic Leukemia Clinical Trial 2023: Alemtuzumab Highlights & Side Effects. Trial Name: NCT03989466 — Phase 1
Alemtuzumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03989466 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what ways has Itacitinib been found to be beneficial for patients?

"Itacitinib is primarily used to manage multiple sclerosis, although it can also be a viable treatment for rejection; kidney transplantation, B-lymphocytes leukemia, T cell chronicity and other conditions."

Answered by AI

Is enrollment for this clinical experiment still attainable?

"Affirmative. Records from clinicaltrials.gov verify that this trial, which first opened for recruitment on January 15th 2020, is still open and inviting participants to apply. The research team requires only 15 volunteers at a single medical centre."

Answered by AI

Has the regulatory body sanctioned Itacitinib for therapeutic use?

"Considering the data available, our team has rated itacitinib's safety at 1. This is due to its status as a Phase one trial, in which there is limited evidence of both efficacy and security."

Answered by AI

Could you enumerate the prior studies utilizing Itacitinib?

"Presently, there are 55 active studies investigating Itacitinib with 4 of these trials in the final phase. These investigations for this drug mostly originate from Philadelphia, Pennsylvania; however, 626 medical centres across the country are conducting relevant clinical trials."

Answered by AI

What is the current enrollment size for this investigation?

"Affirmative. Clinicaltrials.gov records suggest that this medical research is actively enrolling participants and requires 15 patients from 1 site. The first posting of the trial was on January 15th 2020 with a recent update occurring June 24th 2022."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Itacitinib and Alemtuzumab in Treating Patients With T-Cell Prolymphocytic Leukemia
2020. "Itacitinib and Alemtuzumab in Treating Patients With T-Cell Prolymphocytic Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03989466.
~3 spots leftby Apr 2025
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